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Zolpidem for Sleep in Children and Adolescents with Autism

This study is looking at how zolpidem, a medication used for sleep, affects sleep in children and adolescents (ages 8 to 17) who have Autism Spectrum Disorder (ASD). Researchers want to see if zolpidem can improve sleep patterns. They will compare zolpidem to a placebo (an inactive substance) over 8 weeks. Success will be measured by changes in sleep patterns, such as how long it takes to fall asleep and different stages of sleep, using special tests like polysomnography (PSG) and actigraphy. The study plans to enroll 26 participants, but its current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled crossover study involving 26 participants. This means participants will receive either zolpidem or a placebo, and neither they nor the researchers will know which they are getting.
What's involved
Participants will have their sleep architecture measured at the beginning of the study, at Week 4, and at Week 8. This involves tests like polysomnography (PSG) and actigraphy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 weeks, with sleep measurements taken at baseline, Week 4, and Week 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05540574

Trial of Zolpidem for Sleep in Children With Autism

Recruiting
PHASE2Ages 8–17InterventionalBasic science
Stanford University
~26 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:ZolpidemPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)
Measured over Baseline, Week 4 and Week 8

Conditions

Autism
Autism Spectrum Disorder

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NCT05540574

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford University

    Stanford, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Antonio Y. Hardan, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Ryan Villacrucis
[email protected]
(650) 736-1235
Email the study team

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Eligibility criteria

Inclusion

Outpatients between 8 and 17 years of age with only 12- 17 years of age at time of consent during year 1
Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2)
Males and females
Availability of polysomnography (PSG) and/or actigraphy data
Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 85% or less and/or total sleep time less than 7 hours and/or wake after sleep onset of more than 30 minutes as measured by polysomnography (PSG) or actigraphy.
care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks
no planned changes in psychosocial and biomedical interventions during the trial
willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial)
requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms).

Exclusion

active suicidal ideation or DSM-5 diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
unstable medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology) and hepatic insufficiency
evidence of a metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism;
pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
individuals taking benzodiazepines, antiepileptic medications when prescribed for seizure disorder/epilepsy, antidepressants, melatonin and centrally-acting antihistamines
history of hypersensitivity to zolpidem
history of severe side effects from zolpidem
history of adequate trial of zolpidem
current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2
history of complex sleep-related behaviors
individuals using alcohol, marijuana and other substances.

What this trial measures

  • Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)Baseline, Week 4 and Week 8